Ignite Creation Date:
2024-05-06 @ 3:00 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02188550
Status:
UNKNOWN
Last Update Posted:
2015-05-19
First Post:
2014-05-09
Brief Title:
Single Arm Trial With Combination of Everolimus and Letrozole in Treatment of Platinum Resistant Relapse or Refractory or Persistent Ovarian CancerEndometrial Cancer
Sponsor:
Sinai Hospital of Baltimore
Organization:
Sinai Hospital of Baltimore
Study Overview
Official Title:
Phase II Single Arm Trial With Combination of Everolimus and Letrozole in Treatment of Platinum Resistant Relapse or Refractory or Persistent Ovarian CancerEndometrial Cancer CRAD001CUS242T
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine if the combination of Everolimus and Letrozole is effective in the treatment of women with either recurrent or persistent epithelial ovarian fallopian tube primary peritoneal or endometrial cancer
Experiments have shown that everolimus Afinitor can prevent cells such as cancer from growing in number Therefore everolimus Afinitor is being tested in specific diseases to stop cells from growing too fast as in cancer
Everolimus Afinitor has been FDA approved for adults with advanced kidney cancer Renal Cell Carcinoma Everolimus Afinitor received approval for patients with subependymal giant cell astrocytoma SEGA a brain tumor seen with genetic conditions called tuberous sclerosis complex TSC who require therapy but are not candidates for surgery Everolimus Afinitor was approved for pancreatic neuroendocrine tumor PNET in patients with unresectable locally advanced or metastatic disease Everolimus Afinitor received approval for the treatment of postmenopausal women with advanced hormone receptor-positive HER2- negative breast cancer advanced HR BC in combination with exemestane after failure of treatment with letrozole or anastrozole Everolimus Afinitor also received approval for the treatment of patients with TSC who have renal angiomyolipoma not requiring immediate surgery
Everolimus Afinitor has been used to treat patients in clinical studies since 2002 and approximately 25645 patients as of 30-Sep-2012 have been treated with everolimus Afinitor
Experiments have shown that everolimus Afinitor can prevent cells such as cancer from growing in number Therefore everolimus Afinitor is being tested in specific diseases to stop cells from growing too fast as in cancer
Everolimus Afinitor has been FDA approved for adults with advanced kidney cancer Renal Cell Carcinoma Everolimus Afinitor received approval for patients with subependymal giant cell astrocytoma SEGA a brain tumor seen with genetic conditions called tuberous sclerosis complex TSC who require therapy but are not candidates for surgery Everolimus Afinitor was approved for pancreatic neuroendocrine tumor PNET in patients with unresectable locally advanced or metastatic disease Everolimus Afinitor received approval for the treatment of postmenopausal women with advanced hormone receptor-positive HER2- negative breast cancer advanced HR BC in combination with exemestane after failure of treatment with letrozole or anastrozole Everolimus Afinitor also received approval for the treatment of patients with TSC who have renal angiomyolipoma not requiring immediate surgery
Everolimus Afinitor has been used to treat patients in clinical studies since 2002 and approximately 25645 patients as of 30-Sep-2012 have been treated with everolimus Afinitor
Detailed Description:
This is a single arm non-randomized open-label study with a combination of everolimus and letrozole once a day dosing Each cycle would be 28days and patients would be scanned after every 3 cycles for response until disease progression is documented
Subjects will take two pills once a day by mouth with a glass of water
Before the study
Subjects will need to have the following exams tests or procedures to find out if they can be in the study These exams tests or procedures are part of regular cancer care and may be done even if subjects do not join the study If subjects have had some of them recently they may not need to be repeated This will be up to your study doctor
Medical history risk and physical examination
Blood tests to measure blood counts blood mineral levels and check liver and kidney function
CT scan or MRI of the abdomen and pelvis to measure detectable tumor
A pregnancy blood test if subjects are capable of becoming pregnant
Urinalysis examination of urine
The European Organization for research and treatment of cancer global quality of life questionnaire C30 QLQ-C30 -This standard questionnaire helps us to measure quality of life This questionnaire will take subjects 15 minutes to complete and will be completed at entry into the study and at week 12 and 24 during the study
Tests will be done for hepatitis B andor C if
Subjects have a risk of having hepatitis B andor C or if subjects live or have lived in specific geographical areas such as Asia Africa Central and South America Eastern Europe and Spain Portugal or Greece
The study doctor thinks it is appropriate
Subjects that have positive hepatitis B or hepatitis C results at screening may be required to take medication for up to 2 weeks before they start everolimus Afinitor treatment
During the Study
If the exams tests and procedures show that subjects can be in the study and they choose to take part then they will need the following tests and procedures They are part of regular cancer care
History and physical examination
Weekly blood tests to measure blood counts blood mineral levels blood clotting and check liver and kidney function
Evaluation of side effects subjects may experience from the study treatment
Tests to having hepatitis B andor C
CT scan or MRI of the abdomen and pelvis every 12 weeks
The European Organization for research and treatment of cancer global quality of life questionnaire C30 QLQ-C30
Subjects will take two pills once a day by mouth with a glass of water
Before the study
Subjects will need to have the following exams tests or procedures to find out if they can be in the study These exams tests or procedures are part of regular cancer care and may be done even if subjects do not join the study If subjects have had some of them recently they may not need to be repeated This will be up to your study doctor
Medical history risk and physical examination
Blood tests to measure blood counts blood mineral levels and check liver and kidney function
CT scan or MRI of the abdomen and pelvis to measure detectable tumor
A pregnancy blood test if subjects are capable of becoming pregnant
Urinalysis examination of urine
The European Organization for research and treatment of cancer global quality of life questionnaire C30 QLQ-C30 -This standard questionnaire helps us to measure quality of life This questionnaire will take subjects 15 minutes to complete and will be completed at entry into the study and at week 12 and 24 during the study
Tests will be done for hepatitis B andor C if
Subjects have a risk of having hepatitis B andor C or if subjects live or have lived in specific geographical areas such as Asia Africa Central and South America Eastern Europe and Spain Portugal or Greece
The study doctor thinks it is appropriate
Subjects that have positive hepatitis B or hepatitis C results at screening may be required to take medication for up to 2 weeks before they start everolimus Afinitor treatment
During the Study
If the exams tests and procedures show that subjects can be in the study and they choose to take part then they will need the following tests and procedures They are part of regular cancer care
History and physical examination
Weekly blood tests to measure blood counts blood mineral levels blood clotting and check liver and kidney function
Evaluation of side effects subjects may experience from the study treatment
Tests to having hepatitis B andor C
CT scan or MRI of the abdomen and pelvis every 12 weeks
The European Organization for research and treatment of cancer global quality of life questionnaire C30 QLQ-C30
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None